FDA Medical Device Recalls (openFDA)
Abaxis Inc: Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer, Catalog No. 400-0028, manufactured by Abaxis Inc., Union City, CA Medical device for use in the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline Phosphatase (ALP), aspartate aminotransferase, calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen in heparinized whole blood, heparinized plasma or serum.
- Recall number
- Z-1155-2010
- Recalling firm
- Abaxis Inc
- Product
- Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer, Catalog No. 400-0028, manufactured by Abaxis Inc., Union City, CA Medical device for use in the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline Phosphatase (ALP), aspartate aminotransferase, calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen in heparinized whole blood, heparinized plasma or serum.
- Status
- Terminated
- Initiated
- 2009-11-16
- Posted
- 2010-03-16
- Terminated
- 2010-12-14
- Reason
- Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results.
- Root cause
- Labeling mix-ups
- Action
- An "URGENT: PRODUCT RECALL NOTICE" dated November 16, 2009, was sent to customers. The notification described the product, issue/impact, and the action/resolution to be taken by the customers. The customers are to discontinue use of the specified lot, contact Abaxis for immediate replacement and complete and return the enclosed Response form within 5 working days. They may fax the form to Abaxis Technical Support at 1-510-315-3140. The customer are requested to ensure all laboratory staff are informed about this notice and retain this notification as a part of their laboratory Quality System documentation. The firm is currently contacting all direct shipment customers. If you have any questions regarding this Product Recall Notice, please contact Abaxis Medical Technical Support at 800-822-2947, extension 6505, or at medtechsupport@abaxis.com.
- Quantity
- 1010 boxes
- Distribution
- Worldwide distribution: USA and Canada, EU and Asia
- Lot, serial or model codes
- Lot number 9284AC2, accidentally labeled as 9285AC2, catalog number 400-0028, expiration date 7/9/2010
- 510(k) numbers
- ["K942782"]
- PMA numbers
- not on file
- Product code
- JFY
- Firm FEI
- 2939693
- Firm city
- Union City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28